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1 December 2011

Food ingredients and packaging

EFSA advises on safety of bisphenol A and confirms review of opinion in 2012

At the request of the European Commission, the European Food Safety Authority (EFSA) has published a statement on bisphenol A (BPA) in response to September 2011 reports by the French Agency for Food, Environmental and Occupational Health and Safety (Anses[1]). Scientific experts on EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) consider overall that the information in the report on health effects of BPA does not change the views expressed by the Panel in its 2010 opinion on the safety of BPA[2]. The Panel explains that Anses’ work was limited to a hazard identification while EFSA has carried out a full risk assessment of BPA[3]. The tolerable daily intake (TDI) for bisphenol A, first established by EFSA in 2006, is set to protect all human populations for lifetime exposure to this substance through the diet.

EFSA has an ongoing programme of monitoring of scientific developments on BPA. Following a preliminary review of new literature, the CEF Panel confirms, as in 2010, that uncertainties remain about the possible relevance to human health of some BPA-related effects observed in rodents at low dose levels. The Panel will reconsider its opinion following further evaluations of new studies and after new data from low dose studies being conducted in the United States become available in 2012.

In order to further investigate the possible divergences between Anses and EFSA’s conclusions and identify uncertainties in the data, the CEF Panel has undertaken a review of new studies emerging on BPA from its ongoing monitoring of the scientific literature. For the majority of possible health effects, the Panel considers that there is no new information in the recent literature that would change its views as expressed in its 2010 opinion. However, the Panel could not yet consider in depth, the relevance for human health of new studies indicating toxicological effects of BPA in animals at low dose levels. New data due to be published from low dose studies conducted in the USA and exploring the uncertainties around BPA may further clarify issues.

EFSA is establishing a multidisciplinary working group of experts to further evaluate new scientific studies and data on bisphenol A as they become available. EFSA continues to closely monitor these developments which will help inform reconsideration of its scientific advice in 2012. EFSA will also liaise closely with US scientific experts on the studies that are currently in progress.

Bisphenol A (BPA) is a chemical that is mainly used in combination with other chemicals to manufacture plastics and resins. In September 2010, the CEF Panel adopted a scientific opinion on the safety of bisphenol A which confirmed the tolerable daily intake (TDI) of 0.05 mg/kg body weight established in a 2006 EFSA opinion. The TDI is an estimate of the amount of a substance, expressed on a body weight basis that can be ingested daily over a lifetime without appreciable risk. The TDI has been set to protect all human populations for lifetime exposure, including the most vulnerable groups such as pregnant and lactating women, infants and young children.

The four stages of the Risk Assessment Process:

Hazard identification - the identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food and feed or group of foods and feeds.

Hazard characterisation - the qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents that may be present in food and feed.

Exposure assessment - the quantitative estimation of the likely exposure of humans and animals to the food and feed derived from the biological, chemical and physical agents that may be present in food and feed.

Risk characterisation - the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.

[1] Agence Nationale de Sécurité sanitaire, de l’alimentation, de l’environnement et du travail (Anses)
[2] EFSA carried out its full risk assessment of bisphenol A and set a tolerable daily intake in 2006. EFSA published further opinions on BPA in 2008 and 2010. ( Scientific Opinion of the CEF Panel on bisphenol A , 2010)
[3] Hazard identification is the first step in risk assessment in which scientists seek to describe the potential of a substance to cause an adverse effect when animals or humans are exposed to that substance; for example, its inherent toxicity or potential to cause disease. A full risk assessment, however, aims to determine the likelihood of such an adverse health effect occurring, taking into account estimated exposure to the substance.
[4] Research is currently being conducted by the US Food and Drug Administration (FDA) as well as the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP).